TDC VELOCE" recall (D.O.R.C. Dutch Opthalmic Research Center Intl B.V.)
Medical deviceClass IIOngoing
Summary: D.O.R.C. Dutch Opthalmic Research Center Intl B.V. is recalling TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;. Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
What is being recalled
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Why
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.
How to tell if yours is affected
1. Article Number: 9268.VIT27; UDI-DI: 08717872031880; 2. Article Number: 9311.27G01; UDI-DI: 08717872035123; 3. Article Number: 9311.27G02; UDI-DI: 08717872035352; 4. Article Number: 9311.27K01; UDI-DI: N/A; 5. Article Number: 9311.27K02; UDI-DI: N/A; 6. Article Number: 9311.27K03; UDI-DI: N/A; 7. Article Number: 9627.G0101; UDI-DI: N/A; 8. Article Number: 9627.G0201; UDI-DI: N/A; 9. Article Number: 9311.27G01-00; UDI-DI: 08717872035321; Lot Numbers: 202511001, 202601070, 51682-*-*-1, 51683-*-*-1, 54025-*-*-1, 54995-*-*-1, 56258-*-*-1, 56259-*-*-1, 64307-*-*-1, 64310-*-*-1, 69018-*-*-1, 75718-*-*-1, 76781-*-*-1, 76810-*-*-1, 77842-*-*-1, 79461-*-*-1, 80339-*-*-1, 80964-*-*-1, 81336-*-*-1, 82214-*-*-1, 82743-*-*-1, 83585-*-*-1, 84581-*-*-1, 85452001, 86070001, 87206001, 90383001, 97231001;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2324-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 30, 2026 |
| Reported | June 17, 2026 |
| Company | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Company location | Zuidland, N/A, Netherlands |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 261 boxes totaling 1566 units |
More recalls from D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · all medical device recalls · recalls from April 2026